An individually randomized trial of a patient and provider level educational intervention to increase anticoagulant use among untreated members with atrial fibrillation and increased risk of stroke (i.e. CHA2DS2-VASc score ≥2). This project is a proof of concept effort, the first trial conducted using Sentinel Infrastructure, and will inform future interventional studies that are designed to utilize existing healthcare data as part of their design.

The Sentinel Operations Center posted a draft surveillance plan for public comment on March 1, 2017 through March 15, 2017. Revised versions were approved by FDA on October 2, 2017, November 24, 2017, and April 19, 2018. The latter was approved for implementation by BRANY IRB on May 2, 2018. A log of changes is included in the revised protocol (v4.0).